PlainRecalls
FDA Devices Moderate Class II Terminated

Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.

Reported: March 11, 2015 Initiated: February 16, 2015 #Z-1226-2015

Product Description

Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.

Reason for Recall

There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.

Details

Recalling Firm
Intuitive Surgical, Inc.
Units Affected
706 units
Distribution
US and Belgium, Brazil, Canada, China, Finland, France, Greece, India, Italy, Japan, Qatar, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom
Location
Sunnyvale, CA

Frequently Asked Questions

What product was recalled? ▼
Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery.. Recalled by Intuitive Surgical, Inc.. Units affected: 706 units.
Why was this product recalled? ▼
There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2015. Severity: Moderate. Recall number: Z-1226-2015.

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